Amylin Pharmaceuticals, Inc. v. Eli Lilly and Company

456 F. App'x 676
CourtCourt of Appeals for the Ninth Circuit
DecidedOctober 31, 2011
Docket11-55939
StatusUnpublished
Cited by14 cases

This text of 456 F. App'x 676 (Amylin Pharmaceuticals, Inc. v. Eli Lilly and Company) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Amylin Pharmaceuticals, Inc. v. Eli Lilly and Company, 456 F. App'x 676 (9th Cir. 2011).

Opinion

MEMORANDUM **

In 2002, Plaintiff-Appellant Amylin Pharmaceuticals, Inc. (“Amylin”), formed an alliance with Defendant-Appellee Eli Lilly and Co. (“Lilly”) to jointly market Amylin’s diabetes drug, exenatide. In 2005, Amylin received approval from the FDA to market exenatide as Byetta, and Amylin and Lilly began promoting Byet-ta pursuant to their agreement. In 2011, Lilly announced that it was entering into another alliance with Boehringer Ingel-heim GmbH (“BI”), to market BI’s diabetes drug, Tradjenta. Amylin demanded that Lilly use a separate sales force to market Tradjenta rather than the sales force that was privy to years of Amylin’s confidential marketing strategies and materials. Lilly refused. Amy-lin sued, requesting the district court enter a temporary restraining order (“TRO”) and preliminary injunction. The district court initially granted the TRO, but after briefing and a hearing, vacated the TRO and denied the injunction. The district court held that Amylin had not shown a likelihood of irreparable harm absent the injunction. Amylin has appealed.

A district court’s decision denying preliminary injunctive relief is subject to limited review. Harris v. Bd. of Supervisors, Los Angeles Cnty., 366 F.3d 754, 760 (9th Cir.2004) (review “limited and deferential”). We may reverse only if the district court abused its discretion or based its decision on an erroneous legal standard or on clearly erroneous findings of fact. FTC v. Enforma Natural Prods., 362 F.3d 1204, 1211-12 (9th Cir.2004). A district court’s conclusions of law are reviewed de novo. Husain v. Olympic Airways, 316 F.3d 829, 835 (9th Cir.2002), aff'd 540 U.S. 644, 124 S.Ct. 1221, 157 L.Ed.2d 1146 (2004).

We recently clarified our “two-part test used to determine whether a district court *678 has abused its discretion. First, we ‘determine de novo whether the trial court identified the correct legal rule to apply to the relief requested.’ ” Cal. Pharmacists Ass’n v. Maxwell-Jolly, 596 F.3d 1098, 1104 (9th Cir.2010), cert, granted, in part on other grounds hy Maxwell-Jolly v. Cal. Pharmacists Ass’n, Inc., — U.S. -, 181 S.Ct. 992, 178 L.Ed.2d 824 (2011), (quoting United States v. Hinkson, 585 F.3d 1247, 1262 (9th Cir.2009) (en banc)). Second, if the district court got the law right, we then “determine whether the trial court’s application of the correct legal standard was (1) ‘illogical,’ (2) ‘implausible,’ or (3) without ‘support in inferences that may be drawn from the facts in the record.’ ” Hinkson, 585 F.3d at 1262 (quoting Anderson v. City of Bessemer City, N.C., 470 U.S. 564, 577, 105 S.Ct. 1504, 84 L.Ed.2d 518 (1985)).

Here, the district court got the law right. It identified the correct legal rule in its TRO and expressly incorporated that standard in its order denying the preliminary injunction. Specifically, the district court, citing Winter v. Natural Res. Def. Council, Inc., 555 U.S. 7, 20, 129 S.Ct. 365, 172 L.Ed.2d 249 (2008), held that “[a] plaintiff seeking a preliminary injunction must establish that he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the public interest.” The district court correctly noted that all four factors of this four-factor test must be satisfied.

The remaining question is whether the district court’s application of this four-factor test was “illogical,” “implausible,” or without “support in inferences that may be drawn from the facts in the record.” Hinkson, 585 F.3d at 1262. We determine that the district court’s application of the test was sound.

Amylin claims that it will lose sales to Tradjenta due to Lilly’s representatives possessing Amylin’s sales strategies for Byetta. Even assuming this is true, however, lost profits due to lost sales generally constitutes the type of harm that is fully compensable through money damages and therefore does not support injunctive relief. Maxwell-Jolly, 563 F.3d at 851. Amylin, as the party seeking injunctive relief, has the burden of making a “clear showing” that it is entitled to injunctive relief, which includes demonstrating a likelihood of irreparable harm. Winter, 555 U.S. at 22,129 S.Ct. 365.

Lilly presented expert testimony and opinion that any damages Amylin might experience in the form of lost sales or lost customers could be calculated through the use of commonly-used, standard economic analyses. Amylin did not proffer any evidence that seriously refutes Lilly’s expert’s conclusion. Lilly’s expert’s qualifications and experience are unchallenged, and the expert declares that he has wide experience calculating these types of damages in similar cases. The district court did not abuse its discretion in relying on the expert’s conclusion.

Amylin also argues that the loss of goodwill and customers it will suffer constitutes irreparable harm sufficient to justify in-junctive relief. Loss of goodwill is an injury that can be considered irreparable, and thus may support injunctive relief. See, e.g., Stuhlbarg Int’l Sales Co., Inc. v. John D. Brush & Co., Inc., 240 F.3d 832, 841 (9th Cir.2001) (“Evidence of threatened loss of prospective customers or goodwill certainly supports a finding of the possibility of irreparable harm.”); see also Rent-A-Center, Inc. v. Canyon Television & Appliance Rental, Inc., 944 F.2d 597, 603 (9th Cir.1991) (same).

*679 The district court found that Amy-lin’s claim that it would lose goodwill was speculative. Amylin supports its claim primarily with the declarations of its own President, Vice President and Senior Marketing Director. Amylin alleges that Lilly will “falsely describ[e] the nature, characteristics and attributes of exenatide,” and that “[t]hese false descriptions will irreparably harm Amylin’s reputation, sales and goodwill.” However, FDA regulations prohibit such false descriptions, and as the district court noted, “Amylin has offered no concrete evidence that Lilly’s sales representatives would risk FDA sanctions to maximize the sales of Tradjenta.”

Amylin also contends that Lilly will no longer vigorously promote Byetta in favor of Tradjenta.

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